Effect of Airway Integrated Nasal Packing With Different Material

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yung-Song Lin, Chi Mei Medical Hospital
ClinicalTrials.gov Identifier:
NCT01562691
First received: March 21, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to determine the effect of integrated airway in nasal packing material foe patients receiving nasal septoplasty surgery.


Condition Intervention Phase
Postoperative Respiratory Complications
Pain, Postoperative.
Procedure: Nasopore
Procedure: airway integrated Nasopore
Procedure: airway-integrated Vaseline gauze
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Nasal Packing Methods:Nasal Packing Was Done With Nasopore@, Airway-integrated Nasopore@ and Airway-integrated Vaseline Gauze

Resource links provided by NLM:


Further study details as provided by Chi Mei Medical Hospital:

Primary Outcome Measures:
  • oxyhemoglobin saturation by pulse oximetry, SpO2 [ Time Frame: SpO2 was measured 30 minutes before operation, ] [ Designated as safety issue: Yes ]
    SpO2 was measured 30 minutes before operation using O2 saturation monitor.

  • change of SpO2 from baseline to 4 hours post-operation [ Time Frame: records of the SpO2 at 4 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 4 hours post-operation

  • change of the SpO2 from baseline to 6 hours post-operation [ Time Frame: records of the SpO2 at 6 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 6 hours post-operation

  • change of the SpO2 from baseline to 12 hours post-operation [ Time Frame: records of the SpO2 at 12 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 12 hours post-operation

  • change of the SpO2 from baseline to 18 hours post-operation [ Time Frame: records of the SpO2 at 18 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 18 hours post-operation

  • change of the SpO2 from baseline to 48 hours post-operation [ Time Frame: records of the SpO2 at 48 hours post-operation ] [ Designated as safety issue: Yes ]
    records of the SpO2 at 48 hours post-operation


Secondary Outcome Measures:
  • postoperation pain [ Time Frame: record of postoperation pain scale at 2 hous post operation ] [ Designated as safety issue: No ]
    record of postoperation pain scale at 2 hours post-operation

  • change of postoperation pain scale from baseline to 4 hours post-operation [ Time Frame: record of postoperation pain scale at 4 hours post-operation ] [ Designated as safety issue: No ]
    record of postoperation pain scale at 4 hours post-operation

  • change of postoperation pain scale from baseline to 6 hours post-operation [ Time Frame: Record of postoperation pain scale at 6 hours post-operation ] [ Designated as safety issue: No ]
    record of postoperation pain scale at 6 hours post-operation


Enrollment: 60
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nasopore only
Packing using nasopore without airway integrated
Procedure: Nasopore
Bilateral nasal packing using Nasopore without airway integrated
Active Comparator: nasopore with airway integrated
packing using airway integrated nasopore
Procedure: airway integrated Nasopore
post nasoseptoplasty with nasal packing using airway integrated Nasopore
Active Comparator: airway-integrated Vaseline gauze
Nasal packing using airway-integrated Vaseline gauze
Procedure: airway-integrated Vaseline gauze
post nasal septoplasty with packing using airway-integrated Vaseline gauze

Detailed Description:

Nasal packing with integrated airway had been claimed to improve body oxygenation following septal surgery. This randomized control study examined the effect of airway integrated with nasal packing, in terms of its improvement on oxygen saturation. Sixty patients with septal deviation and hypertrophic turbinate were randomized into three groups. Group 1 patients were packed with only nasopore@ after surgery. Nasopore@ with integrated airway was used for group 2 patients; and Vaseline gauze integrated with airway for group 3 patients. Hemodynamic parameters were sequentially checked. Nasal pain sensation was recorded using visual analog scale.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who underwent septoplasty for septal deviation and chronic hypertrophic rhinitis

Exclusion Criteria:

  • patients with comorbidities of coronary heart disease, arrhythmia, chronic obstructive lung diseases, and with past history of any nasal surgery were excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562691

Locations
Taiwan
Chi Mei Medical Center
Tainan, Taiwan, 70014
Sponsors and Collaborators
Chi Mei Medical Hospital
Investigators
Study Chair: Yung-Song Lin, M.D. Chi Mei Medical Hospital
  More Information

No publications provided

Responsible Party: Yung-Song Lin, Chairman of department of Otolaryngology, Chi Mei Medical Hospital
ClinicalTrials.gov Identifier: NCT01562691     History of Changes
Other Study ID Numbers: CMH-09706-001
Study First Received: March 21, 2012
Last Updated: March 23, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chi Mei Medical Hospital:
nasal packing
nasal airway
septoplasty
oxygen saturation
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014